STX-001 + pembrolizumab

**STX-001 + pembrolizumab** is an investigational combination therapy being evaluated mainly in advanced solid tumors. **STX-001** is an LNP-encapsulated (lipid nanoparticle) self-replicating synthetic mRNA therapy engineered to express the cytokine IL-12 within the tumor microenvironment, stimulating robust immune activation through cytokine signaling and increased infiltration of immune cells. **Pembrolizumab** is a PD-1 inhibitory monoclonal antibody (immune checkpoint inhibitor) marketed as Keytruda, which blocks the interaction between PD-1 and its ligands, reinvigorating T cell activity against cancer. The combination aims to synergistically enhance antitumor immune responses: STX-001 locally induces IL-12-driven immune activation, while pembrolizumab systemically removes checkpoint inhibition. This approach is currently under evaluation in a Phase 1/2 trial for safety, pharmacokinetics, preliminary efficacy, and immune biomarkers in patients with treatment-refractory advanced solid tumors, with expansion cohorts focusing on melanoma and triple negative breast cancer[1][2][3][5][7][8].

Other names

STX-001 + Keytruda